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健康青春期前女学生每日补充三种不同剂量维生素D3:一项整群随机试验

Supplementation with Three Different Daily Doses of Vitamin D3 in Healthy Pre-pubertal School Girls: A Cluster Randomized Trial.

作者信息

Marwaha Raman Kumar, Mithal A, Bhari Neetu, Sethuraman G, Gupta Sushil, Shukla Manoj, Narang Archana, Chadda Aditi, Gupta Nandita, Sreenivas V, Ganie M A

机构信息

International Life Sciences Institute, India. Correspondence to: Maj Gen Raman Kumar Marwaha, Scientific Advisor (Projects), International Life Science Institute (India).

Medanta Hospital Gurgaon, Haryana, India.

出版信息

Indian Pediatr. 2018 Nov 15;55(11):951-956.

PMID:30587642
Abstract

OBJECTIVE

To compare the adequacy and efficacy of different doses of vitamin D3 in pre-pubertal girls.

DESIGN

Cluster Randomized controlled trial.

SETTING

Public school in Delhi, India, between August 2015 and February 2016.

PARTICIPANTS

216 healthy pre-pubertal girls, aged 6.1-11.8 years.

INTERVENTION

Daily supplementation with 600 IU (n=74), 1000 IU (n=67) or 2000 IU (n=75) of vitamin D3 under supervision for 6 months.

OUTCOME MEASURES

Primary: Rise in serum 25 hydroxy Vitamin D (25(OH)D); Secondary: Change in bone formation and resorption markers.

RESULTS

Following 6 months of supplementation, the mean (SD) rise in serum 25(OH)D was maximum with 2000 IU (24.09 (8.28) ng/mL), followed by with 1000 IU (17.96 (6.55) ng/mL) and 600 IU (15.48 (7.00) ng/mL). Serum 25(OH)D levels of ≥20 ng/mL were seen in 91% in 600 IU group , 97% in 1000 IU group and 100% in 2000 IU group. The overall mean (SD) rise in urinary calcium creatinine ratio (0.05 (0.28) to 0.13 (0.12) mg/mg), and serum procollagen type I N-terminal propeptide (538.9 (199.78) to 655.5 (218.24) ng/mL), and reduction in serum carboxy-terminal telopeptide (0.745 (0.23) to 0.382 (0.23) ng/mL) was significant (P<0.01). The change in the above parameters was comparable among the three groups after adjustment for age.

CONCLUSIONS

Daily vitamin D supplementation with 600 IU to 2000 IU for 6 months results in Vitamin D sufficiency in >90% of pre-pubertal girls.

摘要

目的

比较不同剂量维生素D3对青春期前女孩的充足性和有效性。

设计

整群随机对照试验。

地点

2015年8月至2016年2月期间,印度德里的公立学校。

参与者

216名健康的青春期前女孩,年龄在6.1 - 11.8岁之间。

干预措施

在监督下每日补充600国际单位(n = 74)、1000国际单位(n = 67)或2000国际单位(n = 75)的维生素D3,持续6个月。

观察指标

主要指标:血清25羟维生素D(25(OH)D)升高;次要指标:骨形成和骨吸收标志物的变化。

结果

补充6个月后,血清25(OH)D的平均(标准差)升高幅度以2000国际单位组最大(24.09(8.28)ng/mL),其次是1000国际单位组(17.96(6.55)ng/mL)和600国际单位组(15.48(7.00)ng/mL)。600国际单位组中91%的女孩血清25(OH)D水平≥20 ng/mL,1000国际单位组为97%,2000国际单位组为100%。尿钙肌酐比值总体平均(标准差)升高(从0.05(0.28)mg/mg至0.13(0.12)mg/mg),血清I型前胶原N端前肽升高(从538.9(199.78)ng/mL至655.5(218.24)ng/mL),血清羧基末端肽降低(从0.745(0.23)ng/mL至0.382(0.23)ng/mL),差异有统计学意义(P<0.01)。调整年龄后,三组上述参数的变化具有可比性。

结论

每日补充600国际单位至2000国际单位的维生素D,持续6个月,可使超过90%的青春期前女孩达到维生素D充足状态。

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